ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)

Enzymatic Method, Bilirubin

Siemens Healthcare Diagnostics, Inc.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia® Chemistry Total Bilirubin_2 (tbil_2).

Pre-market Notification Details

• Device ID: K170065
• 510k Number: K170065
• Device Name: ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
• Classification: Enzymatic Method, Bilirubin
• Applicant: Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591
• Contact: Julie Warren
• Correspondent: Julie Warren; Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591
• Product Code: JFM
• CFR Regulation Number: 862.1110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-01-09
• Decision Date: 2017-03-09
• Summary: summary